MAUDE Adverse Event Report: IRIS INTERNATIONAL ICHEM VELOCITY; AUTOMATED URINE CHEMISTRY ANALYZER

Catalog Number 700-7177-001

Device Problems Charred (1086); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2013

Event Type  malfunction  

Event Description

An iris field service engineer (fse) observed the doser fluid system (dfs) z axis motor flex cable was partially disconnected and melted on the flex cable.

Manufacturer Narrative

During service visit on ichem velocity, fse observed the doser fluid system 2 axis motor flex cable was partially disconnected and melted the flex cable.Fse replaced the board and flex cable and calibrated the cgm.Fse completed velocity performance verification checklist and observed pt samples running normally.System was operational.There were no reports of injuries, visible flames, smoke emission, and the fire department was not called.

• Brand Name: ICHEM VELOCITY
• Type of Device: AUTOMATED URINE CHEMISTRY ANALYZER
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: sudha gupta ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277272
• MDR Report Key: 4272831
• MDR Text Key: 21447105
• Report Number: 2023446-2014-00163
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700-7177-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1